Roles owning submissions, agency interactions and regulatory strategy across FDA, EMA and other health authorities.
352 roles found · page 11 of 15
Vaxcyte · San Carlos, CA
BridgeBio Pharma · 1800 Owens
Twist Bioscience · South San Francisco, CA
Vaxcyte · San Carlos, CA
Orchard Therapeutics
Becton Dickinson · Franklin Lakes, NJ
Merit Medical · South Jordan, UT
Abbott · Pleasanton, CA
Gilead Sciences · Santa Monica, CA +3 more
AbbVie · Cambridge, MA
Becton Dickinson · Franklin Lakes, NJ
AbbVie · North Chicago, IL
AbbVie · Florham Park, NJ
Merck · North Wales (upper Gwynedd), PA +1 more
Merck · North Wales (upper Gwynedd), PA +2 more
Thermo Fisher Scientific · Allentown, PA
Corcept Therapeutics · Redwood City, CA
Rapport Therapeutics · Boston, MA
Keros Therapeutics · MA Hybrid +1 more
Stoke Therapeutics · Bedford, MA
Genmab · Princeton, NJ
Kymera Therapeutics · Watertown, MA
AstraZeneca · Boston, MA +1 more
Abbott · Santa Clara
Regeneron · Sleepy Hollow
Regulatory affairs is the interface between a company and the health authorities that decide whether its product reaches patients. The work spans strategy (what evidence a filing needs and when), operations (assembling and publishing submissions in eCTD format), and labelling and advertising review post-approval. Drug-side roles are framed around INDs, NDAs, BLAs and MAAs; device-side roles around 510(k), De Novo, PMA and EU MDR technical documentation — the two tracks are related but rarely interchangeable, so postings usually specify.
Roles in this area are also listed as regulatory affairs jobs, RA jobs, regulatory submissions jobs and regulatory strategy jobs.
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